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| |  Certolizumab Pegol Provides Important Benefits in Patients With Rheumatoid Arthritis: Presented at EULAR By Genie Benoist PARIS -- June 15, 2008 -- Certolizumab pegol provides rapid and sustained improvements in physical function and health-related quality of life in patients with rheumatoid arthritis (RA) who are on stable methotrexate therapy, investigators reported here on June 13 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. Vibeke Strand, MD, Stanford University School of Medicine, Portola Valley, California, and colleagues examined the kinetics of clinically meaningful improvements in physical function and health-related quality of life after treatment with subcutaneous certolizumab pegol as add-on therapy to methotrexate in patients with active RA, despite treatment with methotrexate. Certolizumab pegol is the first PEGylated anti-TNF Fabī fragment and has been evaluated for use in patients with Crohn's disease. For their analysis, the investigators used data from Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 and 2 trials, both of which were phase 3, randomised, controlled trials that evaluated the efficacy and safety of certolizumab pegol (400 mg at weeks 0, 2, and 4, followed by 200 or 400 mg every 2 weeks) or placebo, added to stable-dose methotrexate in patients with RA. RAPID 2 was a 619-patient, 24-week trial, and RAPID 1 was a 982-patient, 52-week trial. The Health Assessment Questionnaire-Disability Index (HAQ-DI) was used to evaluate physical function and the Short Form-36 Health Survey (SF-36) was used for health-related quality of life. Minimum clinically important differences (MCID) were defined as >=0.22 for the HAQ-DI and >=2.5 for the SF-36 Physical and Mental Component Summary scores (PCS, MCS). Results showed that as early as the first or second weeks throughout both trials, adjusted mean changes from baseline in HAQ-DI in patients treated with the study drug were significantly larger than placebo (P < .001) and surpassed the MCID threshold. At the end of the 52-week trial, 83% of patients receiving certolizumab pegol 200 mg and 86% of those receiving the 400-mg dose, who remained on treatment, had improvements in HAQ-DI >=MCID. The figures were 90.3% for the 200-mg dose and 78.9% for the 400-mg dose at the end of the 24-week trial. From the first assessment (week 12) throughout both studies, adjusted mean changes from the start of the trial in SF-36 PCS and MCS scores in patients receiving certolizumab pegol at both doses were significantly better than for placebo (P < .001) and exceeded the MCID threshold. Overall, the data demonstrate that patients with RA experience significant and clinically meaningful improvements in physical function and health-related quality of life following treatment with certolizumab pegol 200 mg and 400 mg as add-on therapy to methotrexate, the authors said. As early as the first assessment -- at the end of the first week for physical function and at the end of the 12th week for health-related quality of life -- patients treated with certolizumab pegol plus methotrexate reported improvements that held up for at least a year, irrespective of the certolizumab pegol dose regimen. Funding for the study was provided by UCB Pharma. [Presentation title: Certolizumab Pegol (CZP) Induces Rapid and Sustained Clinically Meaningful Improvements in Physical Function and Health-Related Quality of Life (HRQOL) in Patients With Rheumatoid Arthritis (RA): The RAPID 1 and 2 Randomised Clinical Trials (RCTS). Abstract FRI0141]
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